12-Month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA.
Phase of Trial: Phase III
Latest Information Update: 20 Dec 2015
At a glance
- Drugs Flibanserin (Primary)
- Indications Decreased libido; Female sexual dysfunction
- Focus Registrational; Therapeutic Use
- Acronyms ROSE
- 20 Dec 2015 Results published in the Annals of Pharmacotherapy
- 11 Dec 2013 Sprout Pharmaceuticals announced in a media release that it had received and appealed the FDA's Complete Response Letter (CRL) for flibanserin for the treatment of HSDD; the CRL was in response to resubmission of data from the Bouquet trials and others.
- 14 Mar 2012 Sprout Pharmaceuticals added as an association as reported by ClinicalTrials.gov.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History